Principal Biostatistician Consultant- Remote in US (Oncology)
Tasks
- Collaborate with cross functional clinical teams
- Contribute to regulatory submissions
- Design statistical methodologies for efficacy and safety
- Develop statistical analysis plans
- Mentor junior biostatisticians
- Oversee SDTM and ADaM datasets
- Oversee TLFs following CDISC standards
- Provide statistical leadership for oncology clinical trials
- Respond to health authority queries
- Select study endpoints and calculate sample sizes
- Support Data Monitoring Committee activities
- Support adaptive designs
- Support interim analyses
Perks/Benefits
Skills/Tech-stack
ADaM | Adaptive Design | Analysis Plan | BLA | Bayesian Methods | Biostatistics | CDISC | Clinical trial | Data Monitoring | Data Monitoring Committee | EMA | FDA | IND | Interim analysis | NDA | Oncology | R | Regulatory Submission | SAS | SDTM | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan | Survival analysis | TLF | Time to Event
Education
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